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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD VERITOR PLUS SYSTEM CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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BD BD VERITOR PLUS SYSTEM CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Model Number PLUS SYSTEM
Device Problem False Negative Result (1225)
Patient Problems Fever (1858); Headache (1880); Cough (4457)
Event Date 10/29/2020
Event Type  malfunction  
Event Description
The rapid/poc test was negative on (b)(6) 2020 using bd veritor plus system via nasopharyngeal swab. A pcr/molecular nasopharyngeal swab was done at the same time and sent to mako laboratories; we received a call on 10/31/2020 stating the pcr was positive. Staff member left work due to symptom onset of headache, scratchy throat, and cough. Forehead temp 99. 4 degrees. Therapy start date: (b)(6) 2020. Fda safety report id# (b)(4).
 
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Brand NameBD VERITOR PLUS SYSTEM
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
BD
waycross GA 31503
MDR Report Key10791607
MDR Text Key215024335
Report NumberMW5097650
Device Sequence Number1
Product Code QKP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPLUS SYSTEM
Device Catalogue Number256066
Device Lot NumberJB202303
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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